Heads or Tails: The reality of health research trials

In the middle of the ocean a group of individuals find themselves on a sinking boat. They spot an island and begin to wave their arms and yell. A few islanders spot them and alert the highest authorities. After much deliberation, assessing the resources at hand, these authorities express their regret and state that they do not have the means to rescue the boat’s crew. They are preoccupied with more severe or long term crises.

All seems to be lost when a filmmaker decides to propose an initiative. Pooling all his money, he ventures out on a helicopter to the boat’s desperate inhabitants and says that he will flip a coin- heads or tails? If the coin lands on what they choose the filmmaker and his team will rescue them. If the coin does not, they will let the crew drown but will rescue the next group of unlucky nautical fanatics. Whichever scenario plays out will be recorded by the filmmaker for his use. The passengers cry in outrage, demanding to know why they and future sailors cannot both be saved. The filmmaker confesses they only have the ability to save one group, either now or in future. It was up to fate, chance, luck, the random flip of a coin, to decide.

Thoughts on this mildly fanatic tale? This was a metaphorical story narrated by my project supervisor and he asked what I thought of the people sinking, the authorities inaction and the filmmaker’s proposal? Does this tale seem just? Was there a loophole in the bizarre situation? If the filmmaker could save a group now why not in future? Why the coin? It all becomes a bit clearer.

Within health sciences, when current resources are not capable of fixing a problem, akin to our islanders unable to help the sinking boat’s crew, any potential solution undergoes a clinical trial. This includes treatments that prevent, cure or manage a condition, such as our filmmaker flying out to help.

An ideal clinical trial looks at two groups of people, both with the same condition. Only one group will receive a treatment that could potentially solve the issue- the intervention group. The other will continue without the benefit- the control group. This allows for a comparison between the intervention and the control groups to see if any improvement occurs due to the introduction of the treatment- a change in the intervention group that did not occur in the control. Who gets allotted to which group is decided by fate, chance, luck, in other words, the random flip of a coin. Just as the coin would decide whether this crew would be saved or one in future. And much like the filmmaker recording away, all this is documented for the consumption of the scientific community.

For example, an individual with tuberculosis (TB) may develop depression and the current treatment for TB may not account for it. A clinical trial for a new therapy to target comorbid depression in TB patients would recruit participants with TB and determine which have depression. Those who do would be included in the trial and randomly assigned to either the intervention or control group. If the former, they would receive the new therapy to potentially better their depressive symptoms. If the latter, despite the researchers’ knowledge of their depression, they would not receive the solution.

Does this tale seem just? The answer isn’t clear and it remains a heavy point of discontent among health clinicians and researchers, whether the end justifies the means. But until a more credible method than the ideal trial emerges this will remain an example of how effective and well meaning solutions are developed, just out of reach of the control group.